GMP+ BA10 Minimum requirements for purchasing - GMP+ D 3.24 Version EN: 1 May 2020
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GMP+ BA10 Minimum requirements for purchasing GMP+ D 3.24 Version EN: 1 May 2020 GMP+ Feed Certification scheme gmpplus.org
GMP+ BA10 Minimum requirements for purchasing - D 3.24 Index INTRODUCTION ...................................................................................................................................... 3 1. GENERAL QUESTIONS BA10 ........................................................................................................... 4 2. CHANGES TO GATEKEEPER PROTOCOLS ....................................................................................... 5 2.1. DO I HAVE TO NOTIFY TO GMP+ INTERNATIONAL IF I USE A GATEKEEPER PROTOCOL? .......................................... 5 2.2. DO I HAVE TO NOTIFY EVERY TIME I USE A GATEKEEPER PROTOCOL? .......................................................................... 5 2.3. DO I HAVE TO INFORM MY CERTIFICATION BODY IF I USE A GATEKEEPER PROTOCOL? ............................................. 5 2.4. OVERVIEW GATEKEEPER PROTOCOLS .............................................................................................................................. 5 2.4.1. The purchase of unprocessed grains, (oil-)seeds and legumes out of a collect chain for use in feed ........................................................................................................................................................................... 7 2.4.2. The purchase of feed additives, foodstuffs and pharma products ...................................................... 8 2.4.2.1. I purchase a certified feed additive via a non-certified intermediate independent sales office. How to notify? .................................................................................................................................................................................. 8 2.4.3. Purchase of former foodstuffs ......................................................................................................................... 9 2.4.4. The purchase of herbs and spices ................................................................................................................ 10 2.4.5. The purchase of processed feed materials ................................................................................................ 11 2.4.5.1. Which are the requirements that allow to sell on fob conditions concerning protocol 4.3.8? ........ 11 2.4.6. The purchase of feed for feed trial ............................................................................................................... 13 2.4.7. The purchase of road transport .................................................................................................................... 14 2.4.8. The purchase of inland waterway transport ............................................................................................ 15 2.4.9. The purchase of storage and transshipment ........................................................................................... 16 2.4.9.1. Does the storage of packaged goods at third parties needs to be GMP+ certified? .......................... 16 Version EN: 1 May 2020 2/17
GMP+ BA10 Minimum requirements for purchasing - D 3.24 Introduction This Question & Answers (Q&A) list provides information about the application of the new GMP+ BA10 Minimum Requirements for Purchasing. The GMP+ BA10 contains the purchase requirements for participants in the GMP+ Feed Certification scheme. The new GMP+ BA10 is published because a number of purchasing requirements have been harmonized with other European feed safety schemes. • There are no significant changes in the acceptance of certificates from other schemes with which we have an interchangeability agreement. • The main changes have to do with the purchase of feed ingredients via gatekeeper protocols. Three new gatekeeper protocols have been added and a number of existing protocols have minor changes in content Version EN: 1 May 2020 3/17
GMP+ BA10 Minimum requirements for purchasing - D 3.24 1. General questions BA10 1. Why have the purchasing requirements been adjusted in consultation with other schemes? The basic principle is: we pursue a level playing field, based on certified chains. To achieve this, it was decided to harmonize the purchasing requirements between the different schemes. 2. What schemes have you collaborated with? We worked with Ovocom, AIC, QS, EFISC-GTP, OQUALIM and pastus+. 3. From which OQUALIM certified companies can I purchase feed? From January 1, 2020, it is only allowed to purchase from OQUALIM certified companies with the scope "RCNA International". An overview of these companies can be found on the website of OQUALIM. 4. How should I read table 3.9 with requirements for purchasing services? Table 3.9 shows the purchase of a certain process step, eg bagging of compound feeds or drying of a feed material (subcontracting). It can also be a series of process steps, for example the complete production of compound feed. If you want to let another company do this, for example because they can do this very well, then that company must be certified. So you buy these process steps from that company. 5. Must all results of analyses be entered in the GMP+ Monitoring database? Yes, unless otherwise stated in the gatekeeper protocol. Note: The results are processed anonymously. The results provide insight into the nature and range of the use of gatekeeper protocols. Based on this, we can, together with other schemes, evaluate and adjust them if necessary. 6. Has a transitional period been established? Yes. The whole of 2020 counts as a transition year. From 1-1-2021, only the new purchasing requirements will apply. Of course you can also apply them earlier. 7. I use a Country Note. Am I obliged to use the new purchasing requirements from BA10? No, you are not obliged to do this. But with the introduction of the new purchasing requirements, the overlap with the Country Notes has increased considerably. A combination is not allowed. As a company you have to make a choice. - You either adhere to the requirements of the Country Note; Or - You adhere to the requirements of the BA10 Version EN: 1 May 2020 4/17
GMP+ BA10 Minimum requirements for purchasing - D 3.24 2. Changes to gatekeeper protocols Here we describe the changes in existing gatekeeper protocols and explain the new gatekeeper protocols. 2.1. Do I have to notify to GMP+ International if I use a gatekeeper protocol? Yes, unless otherwise stated in the gatekeeper protocol. It is a digital notification We will return a standard confirmation of receipt. After receipt you can immediately apply the protocol. Please note: an exception is the notification regarding the protocol for processed feed materials. In that case we will assess the notification. You can only apply the protocol after approval. 2.2. Do I have to notify every time I use a gatekeeper protocol? Yes, unless otherwise stated in the gatekeeper protocol. Think of any new product / country combination or product / producer combination. Check this carefully in the gatekeeper protocol. Examples of product / country combination: - Suppose you only buy maize from Romania (GMP+ BA10, 4.3.2), you have to make one notification. If you are also going to buy maize from Serbia, you must notify this as well. Examples of product / producer combination: - Suppose you buy sunflower seeds expeller from producer X from Ukraine (GMP+ BA10, 4.3.8). You must notify this once in the first batch. If you also buy sunflower seeds from producer Y from Ukraine, you must also notify this. 2.3. Do I have to inform my Certification Body if I use a gatekeeper protocol? Yes, you must inform the Certification Body (CB) yourself. Ask the CB how to file the notification. GMP+ International periodically sends an overview of notifications to the certification bodies. 2.4. Overview Gatekeeper protocols Gatekeeper protocols New / modified protocols Changes 4.3.1 - Purchase of unprocessed No agricultural products from grower for use in or as feed (including hay and straw) 4.3.2 - Purchase of unprocessed Yes, see 2.4.1 grains, (oil)seeds and legumes out of a collect chain for use in feed Purchase of feed additives 4.3.3 -Purchase of feed Yes, see 2.4.2 additives, foodstuffs, pharma products Purchase of (former) foodstuffs 4.3.4 - Purchase of former Yes, see 2.4.3 foodstuffs 4.3.5 - Purchase of palm oil No Version EN: 1 May 2020 5/17
GMP+ BA10 Minimum requirements for purchasing - D 3.24 4.3.7 - Purchase of herbs and Yes, see 2.4.4 spices 4.3.8 - Purchase of (other) Yes, see 2.4.5 processed feed materials 4.3.9 - Purchase of feed for a Yes, see 2.4.6 feed trial 4.4.1 Purchase of road transport Yes, see 2.4.7 4.4.2 Purchase of inland waterway Yes, see 2.4.8 transport 4.4.3. Purchase of storage and Yes, see 2.4.9 transshipment Version EN: 1 May 2020 6/17
GMP+ BA10 Minimum requirements for purchasing - D 3.24 2.4.1. The purchase of unprocessed grains, (oil-)seeds and legumes out of a collect chain for use in feed What has changed? 1. In the new requirements it is only relevant where unprocessed grains, (oil-)seeds and legumes have been grown, regardless of where the collector is located. 2. Salmonella and heavy metals must now be analyzed with each batch. This has been established in consultation with other schemes, making it possible for GMP+ participants to apply this protocol in advance for the deliveries of unprocessed grains, (oil-)seeds and legumes to other schemes. However, the need for 100% analysis for salmonella in these raw products will be reassessed in the course of 2020. What are the details? 1. Sampling in storage. It is possible to sample a batch in storage. This batch must be kept separate at the storage location until it has been sampled, analyzed and released. You can then deliver this batch directly to the final recipient. Example sampling batch in storage - Suppose you want to transport the batch by trucks from the storage location. Because the batch has already been sampled, analyzed and released (GMP+ assured) at the storage location, you are not obliged to also analyze every 20th truck. This also applies if you deliver to multiple recipients. - Suppose you want to store several smaller deliveries together as one batch. Then you must keep this batch separate until it has been sampled, analyzed and released. You can then use this batch for the production of GMP+ feed. 2. If you receive grains or oilseeds by truck from various (non-assured) origins, you must sample each truck. You must analyze every 20th sample, unless you can store the loads and regard them as 1 batch and sample them (see 1). 3. Analyzing pesticides on the basis of a risk analysis. When it is certain that certain pesticides have not been or are not used during cultivation, you do not need to analyze them. Version EN: 1 May 2020 7/17
GMP+ BA10 Minimum requirements for purchasing - D 3.24 2.4.2. The purchase of feed additives, foodstuffs and pharma products Within this protocol, additives, foodstuffs and pharma products can be purchased worldwide. It is necessary to make an HACCP study yourself and to base measures, checks and inspections on it. What has changed? 1. The scope of this protocol has been extended. In addition to purchasing additives, you can now also buy foodstuffs and pharma products. Previously, foodstuffs were purchased through the ‘protocol for the purchase of (former) foodstuffs’. Let op: a) Foodstuffs are products, processed, partially processed or unprocessed, which are intended to be consumed by humans or which can reasonably be expected to be consumed by humans. b) Former foodstuffs are processed, partially processed or unprocessed products that have been grown / produced for human consumption, but have not been marketed as food by the food business and are no longer intended for human consumption due to manufacturing or packaging defects or other defects. 2. Food additives can be purchased as foodstuffs insofar as they have been produced under a GFSI recognized scheme. 3. You can purchase dairy raw materials originally intended for food in several ways: - Dairy products for use in feed, which are produced under EU Reg. 853/2004. See table 3.4.2 in the new BA10. - Dairy products, which are not produced under 853/2004, but under a GFSI-approved scheme, can be purchased under this protocol - Dairy raw materials that are neither under GFSI nor under EU Reg. 853/2004 are classified as former foodstuffs. See section 4.3.4. of the new BA10. 4. All feed additives that are authorized as feed additives within the EU and non-EU countries may be purchased. 5. All pharma products manufactured under European pharmacopoeia or an equivalent pharmacopoeia may be purchased. It is important that you check whether the product is permitted for use in feed. Check the legislation! 2.4.2.1. I purchase a certified feed additive via a non-certified intermediate independent sales office. How to notify? In some countries, GMP+ certified companies can only buy feed additives, produced under certification, via a single independent sales office. This independent sales office is most of the time not (yet) GMP+ certified. The feed additive is delivered in the producer's original packaging. Because the purchase and invoicing are done via a non-GMP+ certified independent sales office, the GMP+ chain is interrupted. For this situation the feed additive gatekeeper protocol can be used. We ask you to fill in the 'Gatekeeper Protocol Notification Form' in the following way: • Additional information: the name and address details of the sales office. • Upload the GMP+ (or equivalent) certificate of the producer. Version EN: 1 May 2020 8/17
GMP+ BA10 Minimum requirements for purchasing - D 3.24 2.4.3. Purchase of former foodstuffs What has changed? 1. The scope of this protocol is limited to the purchase of former foodstuffs. 2. The witness audit by the certification body has been replaced by another form of supervision of the quality of the supplier audit. When a gatekeeper protocol is used, GMP+ International is allowed to be present during a supplier audit. How we are going to do this is still under discussion. 3. The FSDS no longer needs to be updated every three years. The requirements state that the HACCP documentation (and also other quality documentation) must be updated if necessary. 4. The qualifications for the person performing the supplier audit are now the responsibility of the certified company. Version EN: 1 May 2020 9/17
GMP+ BA10 Minimum requirements for purchasing - D 3.24 2.4.4. The purchase of herbs and spices This is a new protocol. What are the details? 1. Within the scope is the purchase of herbs and spices from any origin. Monitoring of each batch is required. The herbs and spices must be approved for use in animal feed; - if the gatekeeper is a producer - in the country where the gatekeeper is located; - if the gatekeeper is a trader - in the country where the product is placed on the market. 2. When production is done according to a GFSI recognized scheme, these herbs and spices may be considered as food and outside the scope of this protocol 3. For Europe, the following herbs and spices are involved: a. Products from the European feed materials catalog (Reg. (EU) No. 68/2013) listed in category 7. - 7.3.1 Bark - 7.4.1 Blossoms, dried - 7.7.1 Leaves, dried - 7.9.1 Liquorice - 7.10.1 Mint b. Products not listed in category 4 or 7 of Part C of the European catalog of feed materials, such as roots, rhizomes, tubers or cereals of a vegetable species. The feed material (carrot or grain) must be mentioned in the list published on the website www.feedmaterialsregister.eu. 4. All relevant herbs and spices are subject to a generic risk assessment included in the FSP. Version EN: 1 May 2020 10/17
GMP+ BA10 Minimum requirements for purchasing - D 3.24 2.4.5. The purchase of processed feed materials This is a new protocol. What are the details? 1. Feed materials can be purchased on the basis of this protocol. Characteristic is that these products have undergone a processing step. Hence the term "processed products". Examples are: - By-products from the milling industry - By-products from the oilseed processing industry - By-products from sugar production 2. Use is limited to specific countries. - For the other processed feed materials, you may only purchase them under this gatekeeper protocol if they are produced outside Germany, the Netherlands, Belgium, Luxembourg, the United Kingdom or Austria and come from suppliers located outside these countries.. - Exceptions apply to a number of products from specific countries, see section 4.3.8.1 3. This protocol can be applied in two ways. For an indefinite period of time, but with monitoring of each batch. The option means that you can continue to buy a feed material from a certain producer for years, provided you analyze each batch for the defined parameters. You should not reduce the frequency and the determined parameters must all be analyzed every time. - For a limited time (max 18 months), with monitoring based on a hazard analysis. This 18-month period is intended for the non-certified producer to set up his own assurance system and have it certified. This must be demonstrated by a contract that the producer has concluded with a certification body. Note: if you want to use this option, you must notify this to GMP+ International, just like with the other protocols. In this case you need to send more information. - Name and address details of the producer - A producer's contract with the certification body - A substantiated monitoring plan GMP+ International checks whether the information sent meets the requirements of the protocol and reports its findings to you. Only then can you use this option. Correct application of the protocol is verified by the auditor. 2.4.5.1. Which are the requirements that allow to sell on fob conditions concerning protocol 4.3.8? 1) First, you have to find out if it is allowed to purchase the feed material as a gatekeeper. The gatekeeping protocol is not allowed to use for the purchase of specific feed materials- countries-combinations. See for this the table in the protocol. You can only buy them from certified companies. 2) If you are allowed to use the gatekeeper protocol for purchase a feed material (so an ‘allowed product’), it might be that there is a trader in between (as an intermediate). The country where Version EN: 1 May 2020 11/17
GMP+ BA10 Minimum requirements for purchasing - D 3.24 the trader is located does not matter if the trader is selling FOB to you. So, even if this trader is located in one of the listed countries, you can still apply the protocol. An example of a situation in which selling on fob conditions is allowed: a German feed producer purchases sunflower meal from Ukraine via a trader located in Belgium. In this case, the trader can sell the product on fob conditions because sunflower meal from Ukraine is an ‘allowed product’. An example of a situation in which selling on fob conditions is NOT applicable: a German feed producer purchase soy bean meal from Brazil via a trader located in The Netherlands. In this case, we are talking about a forbidden product, gatekeeping is not allowed. Protocol cannot be used at all. Version EN: 1 May 2020 12/17
GMP+ BA10 Minimum requirements for purchasing - D 3.24 2.4.6. The purchase of feed for feed trial This is a new protocol. What are the details? 1. You can apply this protocol if you are conducting a feed test, for example testing a new feed material. These feed materials often do not come from certified producers and are sometimes not registered on the list of permitted products (GMP+ product list). If applied correctly, the feed produced has the GMP+ status. 2. It is necessary to monitor every purchased batch. 3. If it concerns a test with an unregistered veterinary medicinal product or unauthorized feed additive, permission from the competent authority is required.. Version EN: 1 May 2020 13/17
GMP+ BA10 Minimum requirements for purchasing - D 3.24 2.4.7. The purchase of road transport What has changed? Some aspects of this protocol have been clarified: 1. The elements of the written agreement for the transport of hay and straw can also be included in the CMR consignment note with the relevant load. 2. Requirements for the use of non-certified loading compartments with “food only” status have now been added to this protocol. - These loading compartments may be used for transporting foodstuffs of vegetable origin (e.g. vegetable fats and oils, flour, sugar, etc.) to feed companies. GMP+ certification of the carrier is not necessary. But the loading compartments must be covered by a third-party HACCP certification. - The regular requirements of the GMP+ FC scheme apply to the transport of by-products from the food industry (peelings, expellers, etc.) and food of animal origin. What are the details? The transport companies, covered via this protocol, are not registered in the GMP+ Company database. As a receiver of the transport, you must therefore take into account that you must ask the GMP+ certified principal if necessary whether the relevant loading compartment / traction unit is assured by him. Version EN: 1 May 2020 14/17
GMP+ BA10 Minimum requirements for purchasing - D 3.24 2.4.8. The purchase of inland waterway transport What has changed? 1. Only companies that are certified for the scope “affreightment of inland waterway transport” may use this protocol. 2. The initial inspection must be carried out by GMP+ auditors / inspectors, accepted for the scope “ affreightment of short sea shipping and inland waterway transport”. What are the details? The guaranteed inland waterway vessels / push barges are not registered in the GMP+ Company database. As a receiver of the transport, you must therefore take into account that you must ask the GMP+ certified principal if necessary whether the relevant inland waterway vessel / push barge is assured by him. Version EN: 1 May 2020 15/17
GMP+ BA10 Minimum requirements for purchasing - D 3.24 2.4.9. The purchase of storage and transshipment What has changed? 1. Austria and Luxembourg have been added to the list of countries where the gatekeeper protocol may not be used. 2. It can be used for post-harvest storage, for fresh, single plant product that is preserved immediately after harvest. What are the details? You carry out an initial inspection at the non-certified storage and transshipment company, to verify that this company guarantees the same level of feed safety as a GMP+ certified company. Whether, after this initial inspection, a periodic check is required for compliance with agreements made, you must determine on the basis of a risk analysis. 2.4.9.1. Does the storage of packaged goods at third parties needs to be GMP+ certified? Storage of packaged goods does not necessarily have to be purchased from a GMP+ certified service provider. The GMP+ certified company can use this protocol in any country. Version EN: 1 May 2020 16/17
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